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Subacute Cutaneous Lupus ErythematosusPhase 3AMETHYST LTENCT06044337

A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

A Phase 3 study testing BIIB059 (litifilimab) in people with Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, run by Biogen at 104 sites in 25 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BIIB059 (litifilimab)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
306 participants
Where
104 sitesin 25 countries
Study dates
3 Oct 2023to 11 Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who completed the parent study (230LE301 [NCT05531565], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52).
  • Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.

Who cannot join

  • Early Part A or Part B parent study (230LE301 [NCT05531565]) treatment terminators (participants who discontinued study treatment before Week 48).
  • Early Part A or Part B parent study terminators [participants who withdrew from parent study participation before Week 52 and did not complete the parent study extended treatment period (ETP)].
  • Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the long-term extension (LTE) study unsuitable in the opinion of the Investigator.
  • NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

104 sites in 25 countries. Contact the study team or a site near you to ask about taking part.

104 sites in 25 countries

Japan14 sites

  • Teikyo University Hospital

    Itabashi-ku, Tokyo-To, 173-8606

  • Kakogawa Central City Hospital

    Kakogawa-shi, Hyōgo, 675-8611

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • St. Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka, 807-8556

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • JCHO Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510

  • NHO Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520

  • Osaka Keisatsu Hospital

    Osaka, Osaka, 543-8922

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

  • University of Fukui Hospital

    Yoshida-gun, Fukui, 910-1193

Other trials in Japan

United States13 sites

  • David Fivenson, MD, Dermatology, PLLC

    Ann Arbor, Michigan, 48103

  • University of Alabama at Birmingham - (UAB)

    Birmingham, Alabama, 35233

  • Thurston Arthritis Research Center

    Chapel Hill, North Carolina, 27599-7280

  • University of Cincinnati Health Physicians Office Dermatology

    Cincinnati, Ohio, 45219

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-8896

  • Duke Dermatology South Durham

    Durham, North Carolina, 27710

  • Precision Comprehensive Clinical Research Solutions

    Grapevine, Texas, 76034

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona, 85032

  • Saint Louis University

    St Louis, Missouri, 63110

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786

Other trials in United States

Brazil9 sites

  • L2IP - Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora, Minas Gerais, 36010-570

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Nucleo de Pesquisa Clinica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90430-001

  • LMK Serviços Médicos S/S Ltda

    Porto Alegre, Rio Grande do Sul, 90480-000

  • IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda

    Rio de Janeiro, 22470-220

  • Clínica SER da Bahia

    Salvador, Estado de Bahia, 40150-150

  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

    Santo Ângelo, Mato Grosso, 78020-500

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

    São Paulo, São Paulo, 04266-010

Other trials in Brazil

China8 sites

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

  • The second Xiangya Hospital of Central South University

    Changsha, Húnánsheng, 410011

  • Dongguan People's Hospital

    Dongguan, Guangdongsheng, 523059

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdongsheng, 510515

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yun'Nan, 650101

  • Hospital for Skin Diseases, Chinese Academy of Medical Sciences

    Nanjing, Jiangsu, 210042

  • Shanghai Skin Disease Hospital

    Shanghai, Shànghaishì, 200443

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518029

Other trials in China

Germany7 sites

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, Lower Saxony, 48455

  • Charité - Campus Charité Mitte

    Berlin, 10117

  • Universitaetsklinikum Carl Gustav Carus TU

    Dresden, Saxony, 01307

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Halle (Saale)

    Halle, Saxony-Anhalt, 06120

  • Universitaetsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Oldenburg AoeR

    Oldenburg, Lower Saxony, 26133

Other trials in Germany

Spain6 sites

  • Hospital del Mar

    Barcelona, 8003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14004

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Rio Hortega

    Valladolid, Cantabria, 47012

Other trials in Spain

France5 sites

  • CHU de Caen - Hopital de la Cote de Nacre

    Caen, Calvados, 14033

  • Hopital Edouard Herriot - CHU Lyon

    Lyon, Rhone, 69003

  • Hopital Saint Eloi

    Montpellier, Herault, 34295

  • Hopital Tenon

    Paris, 75020

  • Hopital Larrey

    Toulouse, Haute Garonne, 31059

Other trials in France

Philippines5 sites

  • Mary Mediatrix Medical Center

    Lipa City, Batangas, 4127

  • University of the Philippines Manila - Philippine General Hospital

    Manila, 1000

  • Jose R. Reyes Memorial Medical Center

    Manila, 1012

  • St. Luke's Medical Center

    Quezon City, National Capital Region (ncr), 1102

  • Lorma Medical Center

    San Fernando City, La Union, La Union, 2500

Other trials in Philippines

Argentina4 sites

  • APRILLUS Asistencia e Investigacion

    Buenos Aires, C1406AGA

  • Instituto CAICI

    Rosario, Santa Fe Province, S2000PBJ

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, Tucumán Province, 4000

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000AXL

Other trials in Argentina

Bulgaria3 sites

  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

    Sofia, Sofia City Province, 1612

  • DCC 'Alexandrovska', EOOD

    Sofia, 1431

  • DCC Focus 5 - MEOH OOD

    Sofia, 1463

Other trials in Bulgaria

Chile3 sites

  • Centro Medico SkinMed

    Las Condes, 7580206

  • CIEC - Centro Internacional de Estudios Clínicos

    Santiago, 8420383

  • Clinical Research Chile SpA

    Valdivia, 5090000

Other trials in Chile

Mexico3 sites

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua City, 31000

  • Centro de investigacion medica y reumatologia

    Guadalajara, 44950

  • Clinstile, S.A. de C.V.

    Mexico City, Mexico City, 06700

Other trials in Mexico

South Korea3 sites

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

United Kingdom3 sites

  • Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2GW

  • Chapel Allerton Hospital

    Chapel Allerton, West Yorkshire, LS7 4SA

  • Whipps Cross University Hospital

    London, Greater London, E11 1NR

Other trials in United Kingdom

Canada2 sites

  • Laser Rejuvenation Clinics, Inc.

    Calgary, Alberta, T2W 4X9

  • DIEX Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

Other trials in Canada

Colombia2 sites

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla, 80020

  • Healthy Medical Center

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Italy2 sites

  • Università degli studi di Firenze

    Florence, 50121

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122

Other trials in Italy

Poland2 sites

  • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Royalderm_Warszawa

    Warsaw, Masovian Voivodeship, 02-962

Other trials in Poland

Serbia2 sites

  • Institute of Rheumatology_Belgrade

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

Other trials in Serbia

Switzerland2 sites

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Lucerne (Luzern), CH-1011

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

Taiwan2 sites

  • Taichung Veterans General Hospital

    Taichung, 407219

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Hungary1 site

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 07632

Other trials in Hungary

Portugal1 site

  • Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)

    Coimbra, Coimbra District, 3000-075

Other trials in Portugal

Slovakia1 site

  • Artromac n.o.

    Košice, 04011

Other trials in Slovakia

Sweden1 site

  • Karolinska Universitetssjukhuset - Solna

    Solna, 17000

Other trials in Sweden

About this study

Official title: A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.

The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301.

Read more

The main objective of the study is to learn more about the long-term safety of litifilimab.

The main question researchers want to answer is:

  • How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are health problems that may or may not be caused by the study drug.

Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).

Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab.

The study will be done as follows:

  • The last visit of parent study 230LE301 will be the first visit of study 230LE305.
  • All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug.
  • Globally, the treatment period will last up to 208 weeks, or 4 years. Participants will have up to 53 study visits during this time.
Read the detailed description

The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.

The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with SLE; to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.

Being tested
BIIB059 (litifilimab)
Medical subject headings
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIB059 (litifilimab)Drug

    Also called litifilimab

    Administered as specified in the treatment arm.

Study groups in NCT06044337
Study groupRoleWhat they receive
BIIB059ExperimentalParticipants will receive BIIB059 (litifilimab) subcutaneously (SC), once every 4 weeks up to Week 204 in the LTE period.
Receives: Drug: BIIB059 (litifilimab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Up to 232 weeks

Secondary outcomes (35)

  1. Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])

    Measured: Up to 232 weeks

  2. Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])

    Measured: Up to 232 weeks

  3. Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])

    Measured: Up to 232 weeks

  4. Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1

    Measured: Up to 232 weeks

  5. Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0

    Measured: Up to 232 weeks

  6. Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Long-Term Extension (LTE) Baseline

    Measured: Day 1 (LTE Baseline) up to 232 weeks

  7. Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at LTE Baseline

    Measured: Day 1 (LTE Baseline) up to 232 weeks

  8. Percentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at LTE Baseline

    Measured: Day 1 (LTE Baseline) up to 232 weeks

  9. Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 Among Participants With a CLA-IGA-R Erythema Score of 0 or 1 at LTE Baseline

    Measured: Day 1 (LTE Baseline) up to 232 weeks

  10. Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline Value(Parent Study) Among Participants With CLA IGA R OMC Score of 0 or 1 and at Least 1 Level Improvement From Baseline Value(Parent Study)

    Measured: Day 1 (LTE Baseline) up to 232 weeks

  11. Percentage of Participants With a CLASI-70 Response Among CLASI-50 Responders at LTE Baseline

    Measured: Day 1 (LTE Baseline) up to 232 weeks

  12. Percentage of Participants With Loss of Response, Defined as an Increase of ≥ 7 Points in CLASI-A Total Score From Baseline

    Measured: Day 1 (LTE Baseline) up to 232 weeks

  13. Percentage of Participants who Achieve a CLASI A Score of 0 to 3

    Measured: Up to 232 weeks

  14. Percentage of Participants who Achieve a CLASI-A Score of 0 to 5

    Measured: Up to 232 weeks

  15. Percentage of Participants With a CLASI-A 0 to 3 Response Among CLASI-A 0 to 3 Responders at LTE Baseline

    Measured: Day 1 (LTE Baseline) up to 232 weeks

  16. Absolute Change From Baseline in CLASI-A Score of Parent Study (NCT05531565) to Week 208

    Measured: Day 1 (Baseline of Parent study) up to 208 weeks

  17. Percent Change From Baseline in CLASI-A Score of Parent Study (NCT05531565) to Week 208

    Measured: Day 1 (Baseline of Parent study) up to 208 weeks

  18. Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From Baseline Value (Parent Study [NCT05531565]) to Week 208

    Measured: Up to 208 weeks

  19. Percent Change in CLASI-D Score From Baseline Value (Parent Study [NCT05531565]) to Week 208

    Measured: Up to 208 weeks

  20. Annualized Mild/Moderate and Severe Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rates

    Measured: Up to 208 weeks

  21. Percentage of Participants With Oral Corticosteroid (OCS) Dose Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)

    Measured: Day 1 (Baseline of Parent study) up to 208 weeks

  22. Percentage of Participants With OCS ≤ 7.5 Milligrams per day (mg/day) Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)

    Measured: Day 1 (Baseline of Parent study) up to 208 weeks

  23. Percentage of Participants With OCS ≤ 5.0 mg/day Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)

    Measured: Day 1 (Baseline of Parent study) up to 208 weeks

  24. Change From Baseline Value (Parent Study [NCT05531565]) in Cutaneous Lupus Erythematosus - Quality of Life (CLE-QoL) at Week 208

    Measured: Baseline, Week 208

  25. Change From Baseline Value (Parent Study [NCT05531565]) in European Quality of Life - 5-Dimensions Questionnaire, 3-Level Version (EQ-5D-3L) at Week 104

    Measured: Baseline, Week 104

  26. Change From Baseline Value (Parent Study [NCT05531565]) in 36-Item Short Form Survey (SF-36) (acute version) at Week 104

    Measured: Baseline, Week 104

  27. Change From Baseline Value (Parent Study [NCT05531565]) in Work Productivity and Activity Impairment (WPAI): Lupus at Week 104

    Measured: Baseline, Week 104

  28. Change From Baseline Value (Parent Study [NCT05531565]) in Patient Health Questionnaire-9 (PHQ-9) at Week 104

    Measured: Baseline, Week 104

  29. Change From Baseline Value (Parent Study [NCT05531565]) in Subject Global Assessment of Skin - Follow-up (SGA-Skin-FU) at Week 208

    Measured: Baseline, Week 208

  30. Change From Baseline Value (Parent Study [NCT05531565]) in Numerical Rating Scale (NRS) for Pain in Skin Rash at Week 208

    Measured: Baseline, Week 208

  31. Change From Baseline Value (Parent Study [NCT05531565]) in Numerical Rating Scale (NRS) for Itch in Skin Rash at Week 208

    Measured: Baseline, Week 208

  32. Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Standard Laboratory Parameters

    Measured: Up to 208 weeks

  33. Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Electrocardiogram (ECG) Results

    Measured: Up to 232 weeks

  34. Number of Participants With Anti-BIIB059 Antibodies in Serum

    Measured: Up to 232 weeks

  35. Serum Concentration of Litifilimab

    Measured: Pre-dose up to 232 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start3 Oct 2023
  3. Primary completion26 Jun 2029 (estimated)
  4. Study completion11 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
306 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06044337
Sponsor's protocol ID
230LE305
Other IDs
2023-504863-17, 2023
Acronym
AMETHYST LTE
Status last verified
Aug 2026
First submitted
23 Aug 2023
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BIIB059 (litifilimab) in people with Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, run by Biogen at 104 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in Japan, United States, Brazil, China, Germany and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to 232 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06044337.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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